Chicago Tribune - December 14, 2001
Jeremy Manier, Tribune staff reporter. Tribune staff reporter Michael Higgins contributed to this report

The court motion by the U.S. Food and Drug Administration escalates a 16-year battle between the Red Cross and regulators, who alleged that violations by the non-profit organization "decreased the margin of safety" for the blood supply.

Although the FDA could not cite specific cases in which patients were harmed, the motion alleged potentially dangerous violations at centers around the country. The lapses included mislabeling blood products containing a potentially dangerous virus, failure to exclude some donors at risk for AIDS or syphilis and performing faulty tests to see if donors might develop anemia from giving blood, the FDA said.

"Unfortunately to date [the Red Cross] has exhibited a corporate culture that has been willing to tolerate an unacceptably low level of quality assurance and lack of concern for the public it is supposed to serve," said the FDA's acting principal deputy commissioner, Bernard A. Schwetz, in a statement.

FDA officials said they are seeking authority from the Washington, D.C., court to levy up to millions of dollars in fines for future Red Cross violations. Schwetz said the group should be held "financially accountable for each unit of blood it fails to manage properly."

The unusually strong indictment comes as the Red Cross is drawing fire on a number of fronts, including a decision to destroy thousands of pints of surplus blood collected after the Sept. 11 terror attacks. The group also has faced questions over the distribution of Sept. 11 relief funds and the forced resignation in October of its director, Dr. Bernadine Healy.

Thursday's action was not expected to affect the availability of blood in Chicago or elsewhere.

Blood used in Chicago comes mostly from the Red Cross and the competing LifeSource Blood Services. Although the Red Cross supplies many major hospitals, including the University of Chicago, Northwestern Memorial and Rush-Presbyterian-St. Luke's Medical Center, LifeSource has been in the region longer and says it accounts for more of the area's blood supply.

Red Cross to fight motion

In a statement Thursday, the Red Cross said it will "vigorously contest" the FDA's motion, which the Red Cross considers beyond the FDA's legal authority. The group said it has invested more than $280 million in safety since entering into a court-ordered consent decree with the FDA in 1993 over safety violations.

"The nation's blood supply has never been safer than it is today," the Red Cross said in the statement. "No organization is more committed to ensuring safety than the Red Cross."

Yet experts said the Red Cross and another large blood supplier, United Blood Services, have shown a puzzling inability to enact basic record-keeping safeguards.

"It's sad and unfortunate that the FDA had to do something," said Dr. Paul Holland, former chairman of the standards committee of the American Association of Blood Banks.

"You hate to see this--the Red Cross has a good name, but clearly in this area they haven't put their energies and efforts into solving these problems, and they clearly had time to do it," said Holland, who heads the independent Sacramento Blood Center.

Mislabeled blood alleged

Experts said one of the most serious Red Cross violations alleged in Thursday's motion was the widespread mislabeling of blood that had tested positive for cytomegalovirus, or CMV. Although healthy patients can receive such blood, it is dangerous for people with weakened immune systems, including infants, bone-marrow transplant patients and people with AIDS.

"It's potentially serious, because for certain patients cytomegalovirus can be fatal," Holland said.

An FDA review of Red Cross records said it found cases in which the organization responded slowly to reports of CMV mislabeling in the Washington, D.C., and Pennsylvania-New Jersey regions.

The FDA said it could not identify specific cases in which the mislabeling led to infections. Officials there said it would be difficult to trace such infections to one cause because the people at risk are so vulnerable to the virus.

Record-keeping assailed

In an inspection of the Red Cross facility in Salt Lake City earlier this year, FDA officials said they found bad record-keeping on blood products that were being held back for further testing. FDA investigator Mary T. Carden said in a court statement filed Thursday that her team also found hundreds of errors in excluding ineligible donors, including those who answered "yes" to the question, "Do you have AIDS or have you ever tested positive for AIDS?"

In each case, Carden said, the Salt Lake City officials "failed to document any explanation, allowed the donors to give blood, and failed to mark the donors for deferral. They simply overlooked these `yes' answers altogether."

The errors were all caught several days later, and the donors were called back to clarify their status, the FDA said. Red Cross officials told the FDA that no HIV-tainted blood was distributed. But FDA officials said such issues should have been resolved face-to-face on the day of donation.

Another problem involved a test used to see if donors are at risk for developing anemia after giving blood, the FDA said. Although the test usually is done by extracting blood from a finger, the Red Cross used an unusual ear lobe puncture--even years after the organization had evidence that the ear lobe test was inaccurate, the FDA said.

FDA inspectors said they found dozens of cases in which Red Cross donors sought medical care for anemia, including one patient who fainted while driving and had a car accident.

Deep concerns expressed

Although the Red Cross said Thursday that it has "achieved great progress" in complying with regulations since the 1993 consent decree, Carden said in her court statement that former Red Cross director Healy had expressed deep concern over the violations in recent years.

Carden said that in a May 2000 meeting with the Red Cross' Board of Governors, Healy said she believed the FDA findings "could have been much worse" because of other issues that the regulators might have identified if they had more time.

In the statement, Carden added, "Dr. Healy also said that she was concerned about [the Red Cross'] computer system and whether [the Red Cross] should even be in the blood business."

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